Trial | NCT04145310  Report issue

Title

BOL-DP-o-04 in Patients With Low Back Pain and Sciatica
A Prospective, Single-Center, Double-Blind, Placebo-Controlled Trial of BOL-DP-o-04 in Patients With Low Back Pain and Sciatica

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    26
The study is aimed to evaluate the pain-relieving effect of BOL-DP-o-04, in addition to SOC, on Low Back Pain and Sciatica.
A Prospective, Single-Center, Double-Blind, Placebo-Controlled Trial of BOL-DP-o-04 in Patients with Low Back Pain and Sciatica. The study is aimed to evaluate the pain-relieving effect of BOL-DP-o-04, in addition to SOC, on Low Back Pain and Sciatica.
Study Started
Nov 27
2018
Primary Completion
Jul 07
2022
Study Completion
Jul 07
2022
Last Update
Dec 08
2022

Drug BOL-DP-o-04 + SCO

sublingual drops

Drug Placebo + SCO

sublingual drops

Arm A Experimental

Arm B Placebo Comparator

Criteria 

Inclusion Criteria:

>18 years of age
Mild to Severe Low Back Pain and/or Sciatica
Imaging studies (CT or MRI) supporting anatomical abnormality that could be the cause of the symptoms
Must be physically and mentally willing and able to comply with the treatment regimen and understand the informed consent and study procedures
Signed and dated Informed Consent Form (ICF)
Non-responsive to standard therapy for at least 1 month

Exclusion Criteria:

VAS Pain Subscale score at Screening is less than 6 (with 0 being no pain and 10 being worse imaginable pain)
Known allergy to cannabis or its components
A patient who is pregnant or intends to become pregnant during the study
A patient who is nursing or intends to nurse during the study
A patient suffering from a mental disorder precluding administration of study drug
Prisoners
A Patient is unable to sign an informed consent form
Unstable angina pectoris
Cardiac insufficiency precluding cannabis administration
Immunosuppressed patients unless BOL-DP-o-04 administration is deemed safe by the treating physician
Known Aspergillus infection
Panic attacks or anxiety unless a psychiatrist allowed BOL-DP-o-04 following intake interview
Any mental/psychiatric illness in first-degree relative in a young patient < 30-year-old.
Patient with congestive heart failure
Subjects who get the following medications: opiates, Primidone, Phenobarbitol, arbamazepine, Rifampicin, Rifabutin, Troglitazone, and Hypericum perforatum
No Results Posted